TCTR20220714001
Recruiting
N/A
ewborn hearing screening in neonates born to mothers with COVID-19 during pregnancy
/A0 sites183 target enrollmentJuly 14, 2022
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hearing screening of neonates born to women who were positive SARS-CoV-2 PCR during pregnancy
- Sponsor
- /A
- Enrollment
- 183
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Neonates born to mothers who were positive SARS\-CoV\-2 PCR during pregnancy or neonates born to healthy women
- •2\. Neonates with normal ear canal
- •3\. Singleton
Exclusion Criteria
- •1\. Family of childhood hearing loss
- •2\. Admitted in neonatal intensive care more than 5 days
- •3\. Hyperbilirubinemia with exchange transfusion
- •4\. Aminoglycoside administration for more than 5 days,
- •5\. Asphyxia or hypoxic ischemic encephalopathy, extracorporeal membrane oxygenation (ECMO)
- •6\. In utero infections of toxoplasmosis, rubella, cytomegalovirus, herpes, syphilis,Zika
- •7\. Craniofacial malformation
- •8\. Syndrome associated with hearing loss
- •9\. Culture\-positive infection associated with sensorineural hearing loss
- •10\. Major birth head injury to skull (for example Skull fracture)
Outcomes
Primary Outcomes
Not specified
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